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. 2013 Oct;84(10):1416-21.
doi: 10.1016/j.resuscitation.2013.04.006. Epub 2013 Apr 16.

Enrollment in research under exception from informed consent: the Patients' Experiences in Emergency Research (PEER) study

Neal W Dickert  1 , Victoria A Mah, Jill M Baren, Michelle H Biros, Prasanthi Govindarajan, Arthur Pancioli, Robert Silbergleit, David W Wright, Rebecca D Pentz
Affiliations

Enrollment in research under exception from informed consent: the Patients' Experiences in Emergency Research (PEER) study

Neal W Dickert et al. Resuscitation. 2013 Oct.

Abstract

Background: Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown.

Methods: The Patients' Experience in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees or their surrogates from 5 sites. Interviews used a structured, interactive guide focusing on acceptance of EFIC enrollment in RAMPART and existing regulatory protections. Simple statistics were generated, and textual data were analyzed for common themes.

Results: 24 enrolled patients and 37 surrogates were successfully interviewed. 49/60 (82%) were glad they or their family member were included in RAMPART; 54/57 (95%) felt research on emergency seizure treatment is important. 43/59 (73%) found their inclusion under EFIC acceptable; 10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant interactions between enrollment attitudes and demographic characteristics, though there were trends toward lower acceptance among interviewees who were non-white, less educated, or had prior research experience. The most common concerns related to lack of consent prior to RAMPART enrollment. Positive responses related to perceived medical benefits, recognition of the impracticality of consent, and wanting doctors to do what needs to be done in emergencies. Many participants had difficulty understanding the trial and EFIC.

Conclusions: Most subjects had positive views of enrollment, and acceptance generally correlated with results of community consultation studies.

Keywords: Community consultation; Ethics; Research ethics; Research in emergency settings; Resuscitation research.

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Conflict of interest statement

Conflict of Interest Statement: The authors report no other significant financial conflicts of interest relevant to this study.

References

    1. U.S. Food and Drug Administration. Title 21 (Code of Federal Regulations), Part 50.24 Protection of Human Subjects. 2004
    1. U.S. Department of Health and Human Services and Food and Drug Administration. Guidance for Institutional Review Boards, clinical investigators, and sponsors: Exception from informed consent requirements for emergency research. [Accessed January 24, 2013, 2012];2011 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf.
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